NCT01562184

Brief Summary

Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2012

Typical duration for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

3.3 years

First QC Date

March 21, 2012

Last Update Submit

November 30, 2015

Conditions

Unipolar DepressionBipolar Depression

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    12 weeks

Secondary Outcomes (2)

  • Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

    12 weeks

  • Montreal Cognitive Assessment (MoCA): Global Cognitive Function

    8 weeks

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Active tDCS

Device: Soterix tDCS device

Sham tDCS

SHAM COMPARATOR

Sham tDCS

Device: Sham tDCS device

Interventions

Sham tDCS deviceDEVICE

Sham tDCS

Sham tDCS
Soterix tDCS deviceDEVICE

Active tDCS

Active tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or above.
  • Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4 weeks.
  • Total score ≥ 20 on the Montgomery-Asberg Depression Rating Scale at study entry.

You may not qualify if:

  • Current episode duration greater than 3 years.
  • Failed more than 3 adequate antidepressant trials in current episode.
  • DSM-IV psychotic disorder.
  • Drug or alcohol abuse or dependence (preceding 3 months).
  • Inadequate response to ECT in the current episode of depression.
  • Rapid clinical response required, e.g., high suicide risk.
  • Significant acute suicide risk, defined as follows: suicide attempt within the previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or has a clear-cut plan for suicide and states that they cannot guarantee that they will call their regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator's opinion, is likely to attempt suicide within the next 6 months.
  • Clinically defined neurological disorder or insult.
  • Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  • Pregnancy.
  • Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Emory University

Atlanta, Georgia, 30322, United States

Location

Sheppard Pratt

Towson, Maryland, 21285, United States

Location

Rowan University

Cherry Hill, New Jersey, 08002, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of New South Wales / Black Dog Institute

Sydney, New South Wales, 2031, Australia

Location

Related Publications (2)

  • Martin DM, McClintock SM, Aaronson ST, Alonzo A, Husain MM, Lisanby SH, McDonald WM, Mohan A, Nikolin S, O'Reardon J, Weickert CS, Loo CK. Pre-treatment attentional processing speed and antidepressant response to transcranial direct current stimulation: Results from an international randomized controlled trial. Brain Stimul. 2018 Nov-Dec;11(6):1282-1290. doi: 10.1016/j.brs.2018.08.011. Epub 2018 Aug 23.

    PMID: 30172724DERIVED

  • Loo CK, Husain MM, McDonald WM, Aaronson S, O'Reardon JP, Alonzo A, Weickert CS, Martin DM, McClintock SM, Mohan A, Lisanby SH; International Consortium of Research in tDCS (ICRT). International randomized-controlled trial of transcranial Direct Current Stimulation in depression. Brain Stimul. 2018 Jan-Feb;11(1):125-133. doi: 10.1016/j.brs.2017.10.011. Epub 2017 Oct 27.

    PMID: 29111077DERIVED

MeSH Terms

Conditions

Depressive DisorderBipolar Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBipolar and Related Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

AU(1)US(5)